Trial Outcomes & Findings for Trial of Rifaximin in the Treatment of Tropical Enteropathy (NCT NCT00858988)

Results Overview

To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

147 participants

Primary outcome timeframe

28 days

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Rifaximin Allocated to rifaximin	Placebo Allocated to placebo
Randomized and Allocation STARTED	74	73
Randomized and Allocation COMPLETED	74	73
Randomized and Allocation NOT COMPLETED	0	0
Analysis STARTED	74	73
Analysis COMPLETED	72	72
Analysis NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rifaximin Allocated to rifaximin	Placebo Allocated to placebo
Analysis Lactulose unable to be detected in urine	2	1

Baseline Characteristics

Trial of Rifaximin in the Treatment of Tropical Enteropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rifaximin n=72 Participants Allocated to rifaximin	Placebo n=72 Participants Allocated to placebo	Total n=144 Participants Total of all reporting groups
Age, Customized Age	47.6 Months STANDARD_DEVIATION 6.5 • n=5 Participants	46.8 Months STANDARD_DEVIATION 7.6 • n=7 Participants	47.2 Months STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later.

Outcome measures

Outcome measures
Measure	Rifaximin n=72 Participants Allocated to rifaximin	Placebo n=72 Participants Allocated to placebo
Difference in the Urinary L:M Ratio Before and After the Intervention	-0.01 Ratio of lactulose-to-mannitol (L:M) exc Standard Deviation 0.12	0.02 Ratio of lactulose-to-mannitol (L:M) exc Standard Deviation 0.16

Adverse Events

Rifaximin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Manary

Washington University School of Medicine in St. Louis

Phone: 314 454-2178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place